regulation

Genetic Future

Category archives for regulation

The recent Government Accountability Office report into the direct-to-consumer genetic testing industry certainly made a splash: it took centre stage at a Congressional hearing on the industry, and garnered media headlines about “bogus” results being generated by testing companies. As I noted at the time of its release, the report is an obscenely one-sided affair:…

In my previous post I quoted from Mary Carmichael’s excellent interview with two officials from the FDA, Alberto Gutierrez and Elizabeth Mansfield (part of her fantastic week-long DNA dilemma series, which you should read in full if you haven’t already). There are numerous nuggets of gold tucked away in this interview that warrant further analysis,…

Two days ago I reported a rumour that the FDA might have convinced genotyping chip provider Illumina to stop providing its products to direct-to-consumer genetic testing companies – a move that would effectively prevent these companies from being able to operate. The rumour seemed plausible at the time, based on two pieces of evidence. Firstly,…

(This is an edited excerpt from an op-ed piece I just wrote for Xconomy, posted here as I think it provides some nuance on my views on regulation of genetic testing that was lacking from my post last week. Some context for new readers: a Congressional investigation into the direct-to-consumer (DTC) genetic testing industry last…

I mentioned last week on Genetic Future that a reporter with the Washington Post, Rob Stein, had emailed the National Society of Genetic Counsellors to search specifically for people with negative experiences of personal genomics for an upcoming article on the industry. At the time I called for personal genomics customers with positive experiences to…

The brief Golden Age of direct-to-consumer genetic testing – in which people could freely gain access to their own genetic information without a doctor’s permission – may be about to draw to a close. In a dramatic week, announcements of investigations into direct-to-consumer genetic testing companies by both the FDA and the US Congress have…

David Clark at Genomics Law Report has a thorough dissection of the recent and highly restrictive laws passed in Germany governing access to genetic testing. You should read the whole thing to get a sense of what happens when governments grab the wrong end of the regulation stick, but here’s the crucial paragraph: The German…

Pharmacogenetics Reporter has a lengthy article (subscription required) on the California bill SB 482, sponsored by personal genomics company 23andMe, which seeks “to distinguish so-called “post-CLIA bioinformatics services” from entities providing laboratory services”. In other words, 23andMe is pushing to have companies purely providing analysis of genetic data regulated separately from those doing the actual laboratory testing.…